Multiple SclerosisNCT06110468
Physical Function, Health and Employment for People With Multiple Sclerosis
A study testing CoreDISTParticipation in people with Multiple Sclerosis, run by Nordlandssykehuset HF at 1 site in Norway.
Trial summary
Employment is low in people with MS, even when physical levels of functioning are high. The purpose of this study is to investigate if an individually tailored intervention combining individualized physiotherapy and work adaptation works better than usual care in terms of reducing barriers for work and improving… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- CoreDISTParticipation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteNorway
- Study dates
- 4 Mar 2024to Dec 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Multiple Sclerosis according to the McDonald's criteria
- Extended Disability Status Scale (EDSS) 0-4
- Being employed, part time or full time, may include various degrees of sick leave, disability pension or AAP.
- Living in the participating 18 municipalities (Hammerfest, Alta, Senja, Målselv, Tromsø, Harstad, Narvik, Fauske, Bodø, Meløy, Vågan, Vestvågøy, Sortland, Hadsel, Rana, Vefsn, Alstadhaug, Brønnøy).
Who cannot join
- Pregnancy at enrolment.
- Exacerbation of symptoms (i.e. relapse) within two weeks prior to enrolment.
- Other serious conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tailored Follow-up for Persons With Multiple Sclerosis to Optimize Physical Functions, Health and Employment: a Prospective Single-blinded Randomized Controlled Trial
Employment is low in people with MS, even when physical levels of functioning are high. The purpose of this study is to investigate if an individually tailored intervention combining individualized physiotherapy and work adaptation works better than usual care in terms of reducing barriers for work and improving levels of physical activity. The utility of the intervention will be investigated in terms of quality adjusted life years, long-term employment status and work-related costs.
Read the detailed description
Physiotherapy and physical activity interventions can reduce fatigue, improve balance, walking, HRQoL, and may improve neuromuscular and physical functioning in people with MS. However, these interventions lack coordination between health care levels and sectors and rarely address vital employment adaptations. Optimizing function and physical activity, when disability is low and neuroplasticity is optimal, can be valuable for maintaining work as levels of fatigue, mobility related symptoms and cognitive disturbances are associated with current employment.
People with an MS-diagnosis who reside in the North of Norway will be identified from patient lists from the neurological out-patient clinics in the participating hospitals. Upon the provision of written informed consent, all participants will undergo baseline testing prior to randomization into either the intervention or the control group. The intervention group will receive a physiotherapy assessment at the hospitals focusing on opportunities for change. Following this assessment they will participate in group training with a municipality physiotherapist twice weekly for six weeks followed by independent training for six weeks. In addition, both participants and their employers will get access to information films on opportunities for work adaptations and the importance of physical activity. Structured meetings with a specially trained employment consultant, the participant and their employer will be held to discuss possible work adaptations. Goals will be set and formally evaluated. Retests will be carried out at week 9, 16 and 52. Registry data on employment will be obtained from the Norwegian labour and welfare administration as a part of a cost-benefit analysis of the intervention.
- Conditions
- Multiple Sclerosis
- Being tested
- CoreDISTParticipation
- Keywords
- Physiotherapy, Employment, Physical activity, Health related quality of life, Cost-benefit
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoreDISTParticipationOther
CoreDISTparticipation is a multi-disciplinary individualized intervention that concurrently combine 1) providing PwMS and their employers with information on MS, possibilities for work-adaptations within the welfare system and the importance of physical activity 2) Structured goal-setting regarding reducing barriers for work and regarding physical function and activity for PwMS 3) A physiotherapy intervention focusing on improving the underlying prerequisites for balance and walking along with high intensive training and promotion of physical activity 4) structured evaluation and adjustment of goals.
| Study group | Role | What they receive |
|---|---|---|
| Intervention, CoreDISTParticpation | Experimental | Week 1-2: a)Videos for PwMS and employers on MS, possible work adaptations, physical activity (PA) and function. b)A meeting between PwMS and a work-consultant (WC). They will decide if the PwMS should discuss the work situation with their employer or if the WC and/or other professionals are needed. c)A clinical assessment with a trained MS-OP-PT to explore possibilities for optimalisation of movement.
Week 3-8: a)A clinical assessment with the mPT building on previous assessment. Goal-setting for function and PA. b)CoreDIST-training in groups, 6 weeks, 1/week. indoors and 1/week outdoors. Independent training 1/week, CoreDISTvideos. c)A follow up meeting regarding work, evaluation of goals with mPT. New goal setting for week 10-15 Week 10-15, Self-administered, digitally supported home training: a)CoreDIST-videos 3x10 min/week b)Training of own choice including elements of high intensity and balance 2x30 minutes per week. c)Week 15: Evaluation of goals regarding work and PA Receives: Other: CoreDISTParticipation |
| Control, usual care | No intervention | Usual care (control group): These participants will continue with their regular routines and will be encouraged to obtain the national and MS-specific recommendation of 150-300 minutes of moderate physical activity or 75 minutes of high intensity physical activity per week or a combination of these, stay employed, continue medical treatment and seek any health care required, including physiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Sclerosis Work Difficulties Questionnaire -23 Norwegian version
How frequently individuals with MS perceive psychological/cognitive (11 items), physical (8 items), external, (4 items) barriers related to work, scored by a 5-point scale (0=best).
Measured: Baseline, 9, 16 and 52 weeks post baseline
Levels of physical activity measured using ActiGraph wGT3x-BT monitors
% of time in mild, moderate, intensive physical activity and sedate time
Measured: Participants will wear device for one week after testing at baseline and at 9, 16 and 52 weeks post baseline
Secondary outcomes (10)
6 meter walk test
Walking distance (meters) within six minutes
Measured: Baseline, 9, 16 and 52 weeks post baseline
Step count using ActiGraph wGT3x-BT monitors
Daily average number of steps
Measured: Participants will wear device for one week after testing at baseline and at 9, 16 and 52 weeks post baseline
Fatigue Severity Scale -Norwegian version
Self-report, 9 items: physical, social and cognitive effects of fatigue, scale:1-7 (high score indicates higher levels of fatigue).
Measured: Baseline, 9, 16 and 52 weeks post baseline
Multiple Sclerosis Walking Scale-12
Self-reported perception of walking, 12 items, score on a 5-point scale. Higher score indicate higher impact of MS on the individuals walking ability.
Measured: Baseline, 9, 16 and 52 weeks post baseline
Mini Balance Evaluation Systems Test (MiniBESTest)
Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3-point scale. Higher score indicate better performance.
Measured: Baseline, 9, 16 and 52 weeks post baseline
Trunk Impairment Scale-modified Norwegian version (TISmodNV)
Trunk control in sitting. 6 items, score on a 2- or 3-point scale, sum range 0-16 points. Higher score indicates higher levels of trunk control.
Measured: Baseline, 9, 16 and 52 weeks post baseline
Postural control measured by AccuGait Optimized force platforms
Measures postural control in standing, tandem, one-leg standing: postural sway of center of pressure.
Measured: Baseline, 9, 16 and 52 weeks post baseline
European Quality of Life 5-Dimension (EQ-5D-5L) + Complementary questions
Self-perceived HRQoL regarding five domains, and a VAS scale (0-100) on overall health.
Complementary questions on sleep, wellbeing, emotions, social relations (advocated by the Norwegian Health Institute). Higher score indicate better self-perveived health.
Measured: Baseline, 9, 16 and 52 weeks post baseline
Multiple Sclerosis Impact Scale 29-Norwegian version
Self-perceived physical (13 items), psychological (9 items) impact on HRQoL, a 5-point scale. Higher score indicate increased impact of MS on the individuals day-to-day life.
Measured: Baseline, 9, 16 and 52 weeks post baseline
Patient Global Impression of Change - physical activity and balance
A global index that is used to rate the response of a condition to a therapy (transition scale). Higher score indicate improvement.
Measured: Baseline, 9, 16 and 52 weeks post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start4 Mar 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordlandssykehuset HF
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health, University Hospital of North Norway, Nord University, UiT The Arctic University of Norway, Helgeland Hospital Trust, University of Tasmania, Norwegian Labour and Welfare Administration
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110468
- Sponsor's protocol ID
- HNF1687-23
- Status last verified
- Nov 2024
- First submitted
- 24 Oct 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Normann B, Sivertsen M, Braaten TB, Melberg HO, Fikke HK, Elvik M, Arntzen EC. A Comprehensive and Structured Follow-Up for Persons With Multiple Sclerosis (CoreDISTparticipation) to Optimize Physical Functions, Health, and Employment: Protocol for a Prospective, Single-Blinded Randomized Controlled Trial and Health Economic Evaluation. JMIR Res Protoc. 2025 Oct 8;14:e74988. doi: 10.2196/74988.
PubMed 41061251
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Follow-up for Persons With Multiple Sclerosis to Optimize Physical Functions, Health and Employment: a Prospective Single-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06110468
- Acronym / sponsor ID
- HNF1687-23
- Conditions
- Multiple Sclerosis
- Keywords
- Physiotherapy, Employment, Physical activity, Health related quality of life, Cost-benefit
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Nordlandssykehuset HFUniversity, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health, University Hospital of North Norway, Nord University, UiT The Arctic University of Norway, Helgeland Hospital Trust, University of Tasmania, Norwegian Labour and Welfare Administration
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Employment is low in people with MS, even when physical levels of functioning are high. The purpose of this study is to investigate if an individually tailored intervention combining individualized physiotherapy and work adaptation works better than usual care in terms of reducing barriers for work and improving levels of physical activity. The utility of the intervention will be investigated in terms of quality adjusted life years, long-term employment status and work-related costs.
Detailed description
Physiotherapy and physical activity interventions can reduce fatigue, improve balance, walking, HRQoL, and may improve neuromuscular and physical functioning in people with MS. However, these interventions lack coordination between health care levels and sectors and rarely address vital employment adaptations. Optimizing function and physical activity, when disability is low and neuroplasticity is optimal, can be valuable for maintaining work as levels of fatigue, mobility related symptoms and cognitive disturbances are associated with current employment.
People with an MS-diagnosis who reside in the North of Norway will be identified from patient lists from the neurological out-patient clinics in the participating hospitals. Upon the provision of written informed consent, all participants will undergo baseline testing prior to randomization into either the intervention or the control group. The intervention group will receive a physiotherapy assessment at the hospitals focusing on opportunities for change. Following this assessment they will participate in group training with a municipality physiotherapist twice weekly for six weeks followed by independent training for six weeks. In addition, both participants and their employers will get access to information films on opportunities for work adaptations and the importance of physical activity. Structured meetings with a specially trained employment consultant, the participant and their employer will be held to discuss possible work adaptations. Goals will be set and formally evaluated. Retests will be carried out at week 9, 16 and 52. Registry data on employment will be obtained from the Norwegian labour and welfare administration as a part of a cost-benefit analysis of the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention, CoreDISTParticpation | Experimental | Other: CoreDISTParticipationWeek 1-2: a)Videos for PwMS and employers on MS, possible work adaptations, physical activity (PA) and function. b)A meeting between PwMS and a work-consultant (WC). They will decide if the PwMS should discuss the work situation with their employer or if the WC and/or other professionals are needed. c)A clinical assessment with a trained MS-OP-PT to explore possibilities for optimalisation of movement. Week 3-8: a)A clinical assessment with the mPT building on previous assessment. Goal-setting for function and PA. b)CoreDIST-training in groups, 6 weeks, 1/week. indoors and 1/week outdoors. Independent training 1/week, CoreDISTvideos. c)A follow up meeting regarding work, evaluation of goals with mPT. New goal setting for week 10-15 Week 10-15, Self-administered, digitally supported home training: a)CoreDIST-videos 3x10 min/week b)Training of own choice including elements of high intensity and balance 2x30 minutes per week. c)Week 15: Evaluation of goals regarding work and PA |
| Control, usual care | No intervention | –Usual care (control group): These participants will continue with their regular routines and will be encouraged to obtain the national and MS-specific recommendation of 150-300 minutes of moderate physical activity or 75 minutes of high intensity physical activity per week or a combination of these, stay employed, continue medical treatment and seek any health care required, including physiotherapy. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with Multiple Sclerosis according to the McDonald's criteria
- Extended Disability Status Scale (EDSS) 0-4
- Being employed, part time or full time, may include various degrees of sick leave, disability pension or AAP.
- Living in the participating 18 municipalities (Hammerfest, Alta, Senja, Målselv, Tromsø, Harstad, Narvik, Fauske, Bodø, Meløy, Vågan, Vestvågøy, Sortland, Hadsel, Rana, Vefsn, Alstadhaug, Brønnøy).
Key exclusion criteria (3 listed)
- Pregnancy at enrolment.
- Exacerbation of symptoms (i.e. relapse) within two weeks prior to enrolment.
- Other serious conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoreDISTParticipationCoreDISTparticipation is a multi-disciplinary individualized intervention that concurrently combine 1) providing PwMS and their employers with information on MS, possibilities for work-adaptations within the welfare system and the importance of physical activity 2) Structured goal-setting regarding reducing barriers for work and regarding physical function and activity for PwMS 3) A physiotherapy intervention focusing on improving the underlying prerequisites for balance and walking along with high intensive training and promotion of physical activity 4) structured evaluation and adjustment of goals. | Other | Intervention, CoreDISTParticpation |
Primary outcome
Multiple Sclerosis Work Difficulties Questionnaire -23 Norwegian version
Time frame: Baseline, 9, 16 and 52 weeks post baseline
How frequently individuals with MS perceive psychological/cognitive (11 items), physical (8 items), external, (4 items) barriers related to work, scored by a 5-point scale (0=best).
Levels of physical activity measured using ActiGraph wGT3x-BT monitors
Time frame: Participants will wear device for one week after testing at baseline and at 9, 16 and 52 weeks post baseline
% of time in mild, moderate, intensive physical activity and sedate time
10 secondary outcomes
6 meter walk test
Time frame: Baseline, 9, 16 and 52 weeks post baseline
Step count using ActiGraph wGT3x-BT monitors
Time frame: Participants will wear device for one week after testing at baseline and at 9, 16 and 52 weeks post baseline
Fatigue Severity Scale -Norwegian version
Time frame: Baseline, 9, 16 and 52 weeks post baseline
Multiple Sclerosis Walking Scale-12
Time frame: Baseline, 9, 16 and 52 weeks post baseline
Mini Balance Evaluation Systems Test (MiniBESTest)
Time frame: Baseline, 9, 16 and 52 weeks post baseline
Trunk Impairment Scale-modified Norwegian version (TISmodNV)
Time frame: Baseline, 9, 16 and 52 weeks post baseline
Postural control measured by AccuGait Optimized force platforms
Time frame: Baseline, 9, 16 and 52 weeks post baseline
European Quality of Life 5-Dimension (EQ-5D-5L) + Complementary questions
Time frame: Baseline, 9, 16 and 52 weeks post baseline
Multiple Sclerosis Impact Scale 29-Norwegian version
Time frame: Baseline, 9, 16 and 52 weeks post baseline
Patient Global Impression of Change - physical activity and balance
Time frame: Baseline, 9, 16 and 52 weeks post baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Derived from this study: PubMed 41061251Normann B, Sivertsen M, Braaten TB, Melberg HO, Fikke HK, Elvik M, Arntzen EC. A Comprehensive and Structured Follow-Up for Persons With Multiple Sclerosis (CoreDISTparticipation) to Optimize Physical Functions, Health, and Employment: Protocol for a Prospective, Single-Blinded Randomized Controlled Trial and Health Economic Evaluation. JMIR Res Protoc. 2025 Oct 8;14:e74988. doi: 10.2196/74988.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoreDISTParticipation in people with Multiple Sclerosis, run by Nordlandssykehuset HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple Sclerosis Work Difficulties Questionnaire -23 Norwegian version (time frame: Baseline, 9, 16 and 52 weeks post baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06110468, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.